U.S. patent application number 11/084688 was filed with the patent office on 2006-09-21 for systems and methods for hemorrhage control and or tissue repair.
Invention is credited to Paul F. IV Bente, Heather Margaret Bryan, Kenton W. Gregory, Jeffrey Yihyuan Lin, Aileen Nuguid, Daniel Allen Pederson.
Application Number | 20060211973 11/084688 |
Document ID | / |
Family ID | 37011331 |
Filed Date | 2006-09-21 |
United States Patent
Application |
20060211973 |
Kind Code |
A1 |
Gregory; Kenton W. ; et
al. |
September 21, 2006 |
Systems and methods for hemorrhage control and or tissue repair
Abstract
A bandage application system of the present for hemorrhage
control and/or tissue repair of the gastrointestinal tract, such as
the gastrointestinal tract is provided. The system comprises a
bandage for hemorrhage control and/or tissue repair of the
gastrointestinal tract. It also includes an apparatus for
introducing the bandage into a treatment area of the
gastrointestinal tract requiring hemorrhage control and/or tissue
repair, and for removing the apparatus from the treatment area
without displacing the bandage from being adhered to the treatment
area, and without damaging the gastrointestinal tract. Furthermore,
it also has a device for adhering the bandage to the treatment
area.
Inventors: |
Gregory; Kenton W.;
(Portland, OR) ; Bente; Paul F. IV; (Brentwood,
CA) ; Bryan; Heather Margaret; (San Francisco,
CA) ; Lin; Jeffrey Yihyuan; (Rowland Heights, CA)
; Nuguid; Aileen; (San Gabriel, CA) ; Pederson;
Daniel Allen; (Winters, CA) |
Correspondence
Address: |
MARGER JOHNSON & MCCOLLOM, P.C.
210 SW MORRISON STREET, SUITE 400
PORTLAND
OR
97204
US
|
Family ID: |
37011331 |
Appl. No.: |
11/084688 |
Filed: |
March 17, 2005 |
Current U.S.
Class: |
602/49 |
Current CPC
Class: |
A61F 2013/00463
20130101; A61F 2002/044 20130101; A61F 2/04 20130101; A61B 17/00234
20130101; A61F 13/148 20130101; A61B 17/1114 20130101; A61F
2002/045 20130101 |
Class at
Publication: |
602/049 |
International
Class: |
A61F 13/00 20060101
A61F013/00 |
Claims
1. A method for hemorrhage control and/or tissue repair of an
esophagus, stomach, duodenum, small intestine and large intestine
which comprises: introducing a bandage into a treatment area of
said esophagus, stomach, duodenum, small intestine and large
intestine requiring hemorrhage control and/or tissue repair with a
bandage application system; adhering the bandage to the treatment
area using said bandage application system; and removing said
bandage application system from said treatment area without
displacing said bandage from being adhered to the treatment area
and without damaging the esophagus.
2. The method of claim 1, wherein the bandage application system is
non-invasive.
3. The method of claim 1, wherein the bandage application system is
employed in conjunction with an endoscopic device.
4. The method of claim 1, wherein the bandage application system is
introduced under video guidance.
5. A method of claim 1, wherein the bandage application system is
introduced under fluoscopic control.
6. The method of claim 1, wherein the bandage application system
adheres the bandage to the treatment by applying pressure to the
bandage against the esophagus, stomach, duodenum, small and large
intestine.
7. The method of claim 6, wherein the bandage application system is
expanded for applying said pressure to move the bandage against the
esophagus, stomach, duodenum, small intestine and large intestine
for a period of time sufficient to adhere said bandage to said
esophagus, stomach, duodenum, small intestine and large
intestine.
8. The method of claim 6, wherein the bandage application system is
expanded using a gas or fluid for applying said pressure to move
the bandage against the esophagus for a period of time sufficient
to adhere said bandage to said esophagus, stomach, duodenum, small
intestine and large intestine.
9. The method of claim 6, wherein the bandage application system
which includes an expandable member which is expanded by air or
fluid for applying said pressure to move the bandage against the
esophagus, stomach, duodenum, small intestine and large intestine
for a period of time sufficient to adhere said bandage to said
esophagus, stomach, duodenum, small intestine and large
intestine.
10. The method of claim 8, wherein the bandage application system
includes a tubular sleeve on which is mounted said expandable
member.
11. The method of claim 1, wherein the bandage is substantially
tubular in shape to encompass all sides of the esophagus, stomach,
duodenum, small intestine and large intestine.
12. The method of claim 1, wherein the bandage comprises a chitosan
bandage.
13. The method of claim 1, wherein the bandage further includes a
protective coating joined to the bandage so that the bandage does
not adhere to the bandage application system or to the esophagus,
stomach, duodenum, small intestine and large intestine en route to
the treatment area.
14. The method of claim 1, wherein an outer sheath is disposed
about the bandage to protect the bandage from the wet environment
of the esophagus, stomach, duodenum, small intestine and large
intestine when introducing said bandage into said treatment
area.
15. A bandage application system for hemorrhage control and/or
tissue repair of an esophagus, stomach, duodenum, small intestine
and large intestine, which comprises: a bandage for hemorrhage
control and/or tissue repair of said esophagus; an apparatus for
introducing said bandage into a treatment area of said esophagus,
stomach, duodenum, small intestine and large intestine requiring
hemorrhage control and/or tissue repair, and for removing said
apparatus from said treatment area without displacing said bandage
from being adhered to the treatment area and without damaging the
esophagus, stomach, duodenum, small intestine and large intestine;
and a device for adhering the bandage to the treatment area.
16. The system of claim 15, which is non-invasive.
17. The system of claim 15, which is employed in conjunction with
an endoscopic device.
18. The system of claim 15, which further includes video guidance
for introducing said bandage into a treatment area.
19. The system of claim 15, wherein the device adheres the bandage
to the treatment area by applying pressure to the bandage against
the esophagus, stomach, duodenum, small intestine and large
intestine.
20. The system of claim 15, wherein the device for adhering the
bandage to the treatment area is expanded for applying said
pressure to move the bandage against the esophagus, stomach,
duodenum, small intestine and large intestine for a period of time
sufficient to adhere said bandage to said esophagus, stomach,
duodenum, small intestine and large intestine.
21. The system of claim 15, wherein the device for adhering the
bandage to the treatment area is expanded using a gas or fluid for
applying said pressure to move the bandage against the esophagus,
stomach, duodenum, small intestine and large intestine for a period
of time sufficient to adhere said bandage to said esophagus,
stomach, duodenum, small intestine and large intestine.
22. The system of claim 15, wherein the device for adhering the
bandage to the treatment area includes an expandable member which
is expanded by gas or fluid for applying said pressure to move the
bandage against the esophagus, stomach, duodenum, small intestine
and large intestine for a period of time sufficient to adhere said
bandage to said esophagus, stomach, duodenum, small intestine and
large intestine.
23. The system of claim 15, wherein the device for adhering the
bandage to the treatment area includes a tubular sleeve on which is
mounted said expandable member.
24. The system of claim 15, wherein the bandage is substantially
tubular in shape to encompass all sides of the esophagus, stomach,
duodenum, small intestine and large intestine.
25. The system of claim 15, wherein the bandage comprises a
chitosan bandage.
26. The system of claim 15, wherein the bandage further includes a
protective coating joined to the bandage so that the bandage does
not adhere to the bandage application system or to the esophagus,
stomach, duodenum, small intestine and large intestine en route to
the treatment area.
27. The system of claim 15, wherein an outer sheath is disposed
about the bandage to protect the bandage from the wet environment
of the esophagus, stomach, duodenum, small intestine and large
intestine when introducing said bandage into said treatment
area.
28. A bandage application system for hemorrhage control and/or
tissue repair of an esophagus, stomach, duodenum, small intestine
and large intestine, which comprises: an endoscopic device; a
bandage for hemorrhage control and/or tissue repair of said
esophagus, stomach, duodenum, small intestine and large intestine;
an apparatus connected to said endoscopic device for introducing
said bandage into a treatment area of said esophagus requiring
hemorrhage control and/or tissue repair, and for removing said
apparatus from said treatment area without displacing said bandage
from being adhered to the treatment area and without damaging the
esophagus; and a device for adhering the bandage to the treatment
area by applying pressure to the bandage against the esophagus.
29. The system of claim 15, wherein tissue repair comprises
surgical anastomosis of said esophagus, stomach, duodenum, small
intestine and large intestine.
30. The system of claim 15, wherein said hemorrhage control and/or
tissue repair comprises treating bleeding or other wounds in the
transurethral prostatectomy.
31. The system of claim 15, wherein said hemorrhage control and/or
tissue repair comprises treating bronchial bleeding, fistulas or
other lesions using a bronchoscope.
32. The system of claim 15, wherein said bandage is in the shape of
a patch.
33. The system of claim 15, wherein said bandage includes drugs for
additional pharmacologic treatment effects.
34. The system of claim 15, wherein said drugs comprise anticancer
drugs, anti inflammatory drugs, anti-ulcerative colitis drugs,
anti-Crohns disease drugs, coagulants, antibiotics, and muscle
relaxants.
35. The system of claim 21, wherein the tubular sleeve is expanded
from a location outside the body.
36. The system of claim 26, wherein said protective covering is
removable from the bandage.
37. The system of claim 15, wherein said bandage is comprised of
chitosan and at least one additional component.
38. The system of claim 15, wherein said bandage is composed of
chitosan acetate.
39. The system of claim 37, wherein said additional components
comprise biocompatible synthetic polymer or natural protein
coatings or coverings.
40. The system of claim 39, wherein said biocompatible protein
coatings comprise elastin or collagen or other matrix proteins.
41. The system of 37, where coatings or coverings comprise Vicryl
or Dexon.
42. The system of claim 15, wherein said bandage is used to treat
an infection such as candidiassis, a viral inflammation or a
bacterial infection.
43. The system of claim 15, wherein said bandage is used to treat
and seal a perforation or fistula or leaking anastomosis.
44. The system of claim 15, wherein the device for adhering the
bandage to the treatment area includes a guide wire system on which
is mounted said expandable member.
45. The system of claim 15, wherein the device for adhering the
bandage to the treatment area includes a nitinol tube on which is
mounted said expandable member.
46. The system of claim 15, wherein said bandage is used to treat
an ulceration or burn.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates to systems and methods for hemorrhage
control and/or tissue repair of the gastrointestinal tract, and
more particularly, an application system and method for effectively
and efficiently bandaging a treatment area of an esophagus,
stomach, duodenum, small intestine and large intestine or other
structures in the gastrointestinal tract requiring hemorrhage
control and/or tissue repair without damaging the gastrointestinal
tract.
[0002] The esophagus is the muscular, membranous tube, through
which food is passed, which extends from the pharynx to the
stomach. Hemorrhage control and tissue repair are difficult to
affect within the esophageal tract.
[0003] The esophagus can be severely injured resulting in
hemorrhage and tissue injury through penetrating trauma or from
forceful emesis causing tears termed Mallory Weiss Tears.
Ulceration of the esophagus and other gastrointestinal tissues can
have hemorrhage and tissue injury. The esophagus is also injured
and perforated by physicians using endoscopes. Surgical resections
of esophageal cancers and other lesions requiring end to end and
other anastomosis can hemorrhage and have tissue injury. In cases
with perforations or surgical resections of the esophagus,
frequently the most serious, life threatening consequences are
caused by leaks of esophageal contents into the mediastinum
resulting in debilitating and life threatening infection due to
lack of adequate sealing of the esophageal injury.
[0004] Esophageal varices are dilated veins of the portal systemic
system which pass through the distal end of the esophagus where it
meets with the lesser curvature of the stomach. These veins dilate
from a diameter of a few millimeters to a diameter of up to 1 cm
due to an increase in blood pressure within them, which pushes
against their thin, elastic walls. This portal hypertension is a
consequence of the blockage in blood flow further down the path of
the portal vein at the liver when fibrosis (scar tissue) is present
due to cirrhosis.
[0005] When the blood through the portal vein cannot follow its
usual path through the liver, it is forced back up the vein in the
direction from which it came. Because the portal vein is not
constructed to withstand such strong forces, it tends to balloon
out at sites of vessel weakness, such as at the base of the
esophagus where the vein passes very close to the surface, causing
what is clinically known as varices. Esophageal varices are a
subject of much concern among the medical community due to the high
rate of occurrence and severe complications of the condition.
Additionally, of the incidents of esophageal varices, 50% of them
will be so severe that the vein will rupture into the esophagus
resulting in critical bleeding situations. Patients presenting with
an initial case of bleeding esophageal varices have a 40-70%
fatality rate, and recurrent bleeding is typical.
[0006] Currently there are few effective acute treatment options
for patients with bleeding esophageal varices. Ideally, a treatment
would be as non-invasive as possible, would not cause any
side-effects, would be effective for all cases presented, and would
allow for the restoration of the patient's daily lifestyle soon
afterward. Unfortunately none of the treatments currently available
offer all of these characteristics.
[0007] Two common treatments for esophageal varices involve the use
of an endoscope to deploy a device at the bleeding site to stop the
bleeding. The endoscope is a tool used in most gastrointestinal
procedures. It is often used for investigation and diagnosis of
upper and lower GI problems. The standard endoscope is a long
tubular device. It has a control held by the doctor that
manipulates the tip, which is inserted down the patient's
esophagus. The endoscope has its own optics system, which is
transmitted to a monitor and possible video sampling or recording
system. Down the center of the endoscope is a 4 mm hole. This hole
is used to insert balloons, forceps or other surgical devices to
perform whatever operation is necessary in the GI tract.
[0008] One of these devices places a rubber band securely around
the opening of the bleeding varix, which simply closes off the
injury to the harsh environment of the gastrointestinal (GI) tract
with the expectation that it will eventually heal over. However,
this method of treatment is only an option for bleeding varices
that are relatively small, whereas most problematic varices are
often very large. The other endoscopic method of treating acute
bleeding in the esophagus utilizes a balloon apparatus which is
extended by a wire down the esophagus, past the esophageal-stomach
junction and into the upper stomach. It is then blown-up and pulled
upwards toward the esophagus. This motion applies pressure to the
esophagus at the esophageal-stomach junction, which acts to stop or
slow down bleeding from the ruptured varices. Unfortunately, this
method is not very effective, and at times physicians find it
necessary to assist the process by pouring ice water down the
esophagus. Ultimately, this procedure is ineffective against large
bleeds, and is only a very temporary solution as it prevents the
passage of food into the stomach.
[0009] The most extreme method of treating esophageal varices
involves the insertion of a transjugular intrahepatic Porto
systemic shunt (TIPS) into the hepatic vein in an effort to reduce
portal venous pressure. Unfortunately the TIPS procedure is a
highly invasive surgery. In addition, it will not cure the
immediate problem of bleeding in the esophagus.
[0010] Therefore, a need exists for effectively and efficiently
controlling esophageal hemorrhaging and/or repairing esophageal or
other gastrointestinal tissues. Similarly, such devices could be
deployed in the urologic tracts such as the urethra using
endoscopic techniques or in the bronchus using bronchoscopes to
treat bleeding, perforations, fistulas or other lesions. The
ability to deploy a dressing that can stop hemorrhage and seal the
lesion, as well as create an antimicrobial barrier, offers great
promise to substantially reduce morbidity as a result of these
injuries that is poorly addressed by present endoscopic and
surgical technologies and techniques. The potential to deliver
dressings that clot and seal these lesions rapidly and safely using
conventional endoscopes would be of great benefit.
SUMMARY OF THE INVENTION
[0011] A bandage application system of the present for hemorrhage
control and/or tissue repair of the gastrointestinal tract, such as
the esophagus, stomach, duodenum, small intestine and large
intestine, can be provided which meets the above-described existing
needs. The system comprises a bandage for hemorrhage control and/or
tissue repair of the gastrointestinal tract. It also includes an
apparatus for introducing the bandage into a treatment area of the
gastrointestinal tract requiring hemorrhage control and/or tissue
repair, and for removing the apparatus from the treatment area
without displacing the bandage from being adhered to the treatment
area, and without damaging the gastrointestinal tract. Furthermore,
it also has a device for adhering the bandage to the treatment
area.
[0012] Preferably, the bandage application system is non-invasive.
Thus, the system is preferably constructed to be employed
conjunction with an endoscopic device. Furthermore, the bandage
application system can be introduced into a treatment area of the
esophagus under video or fluoroscopic guidance.
[0013] The bandage application system can be designed to adhere the
bandage to the treatment area by applying pressure to the bandage
against the esophagus. More specifically, the bandage application
system can be expanded for applying pressure to move the bandage
against the esophagus for a period of time sufficient to adhere the
bandage to the esophagus.
[0014] Furthermore, the bandage application system can be expanded
using a gas for applying the pressure to move the bandage against
the esophagus for a period of time sufficient to adhere the bandage
to the esophagus. Thus, the system can include an expandable member
which is expanded by applying the pressure, typically employing air
or fluid as the expansion medium, to move the bandage against the
esophagus for a period of time sufficient to adhere the bandage to
the esophagus. The bandage application system can include a tubular
sleeve on which is mounted the expandable member.
[0015] The bandage can be formed into a generally substantially
tubular shape to encompass all sides of the esophagus. The bandage
preferably comprises a chitosan bandage. Preferably, the bandage
further includes a protective barrier joined to the bandage so that
the bandage does not adhere to the bandage application system or to
the esophagus en route to the treatment area. An outer sheath can
also be disposed about the bandage to protect the bandage from the
wet environment of the esophagus when introducing the bandage into
the treatment area.
[0016] In one embodiment the treatment includes application of the
endoscopic chitosan bandage delivery system to a bleeding or
ulcerous lesion in the esophagus, stomach, duodenum, small or large
intestine. In one embodiment, tissue repair comprises surgical
anastomosis of the esophagus, stomach, duodenum, small intestine
and large intestine. In another embodiment, hemorrhage control
and/or tissue repair comprises treating bleeding or other wounds in
the transurethral prostatectomy. In still another embodiment,
hemorrhage control and/or tissue repair comprises treating
bronchial bleeding, fistulas or other lesions using a
bronchoscope.
[0017] The bandage of the present invention can include drugs for
additional pharmacologic treatment effects. Preferably, these drugs
can comprise anticancer drugs, anti inflammatory drugs,
anti-ulcerative colitis drugs, anti-Crohns disease drugs,
coagulants, antibiotics, and muscle relaxants.
[0018] The system of preferably includes a bandage which is in the
shape of a patch. Furthermore, a protective covering can be
provided which is removable from the bandage. In one form of the
invention, the bandage is comprised of chitosan and at least one
additional component. Preferably, the bandage is comprised of
chitosan acetate. As for the additional components, they preferably
comprise biocompatible synthetic polymer or natural protein
coatings, and the biocompatible protein coatings preferably
comprise elastin or collagen or other matrix proteins.
[0019] The bandage can be used to treat an ulceration or burn. It
can also be used to treat an infection such as candidiassis, a
viral inflammation or a bacterial infection, or to treat and seal a
perforation or fistula or leaking anastomosis.
[0020] The system of this invention can be configured so that the
tubular sleeve is expanded from a location outside the body. And,
the device for adhering the bandage to the treatment area can
include a guidewire system on which is mounted the expandable
member. Moreover, the device for adhering the bandage to the
treatment area can include an expandable nitinol tube on which is
mounted said expandable member.
DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is a perspective view of a preferred system of the
present invention.
[0022] FIG. 2 is an exploded perspective view of the system of FIG.
1.
[0023] FIG. 3 is perspective view of the system of FIG. 1 having a
bandage wrapped around the system.
[0024] FIG. 4 is perspective view of the system of FIG. 3 having a
protective sheath wrapped around the bandage.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENT
[0025] Referring to FIGS. 1 and 2, the system 10 of the present
invention is compatible with currently available endoscopes.
Current available endoscopes (not shown) have optics wired inside
of them so that the physician can view the area at the tip of the
endoscope on a large monitor. This will aid in quick employment of
the system 10 because medical facilities would not need to purchase
new, costly endoscopic equipment. Permanent alterations to existing
endoscopes would narrow the range of usage of those altered
endoscopes. Therefore, the system should not require permanent
attachment or alterations to endoscopes which are used to deploy
it. To best meet this objective, the system should be detachable
after use.
[0026] It is important to the success of the system 10 that it be
able to accurately deliver the bandage to the treatment used.
Accurate delivery typically involves the application of one or more
bandages such that the entire treatment area is covered. The system
of this invention is designed for reproducible accuracy.
[0027] The speed of effectual application of a bandage 50 (see FIG.
3) after diagnosis of the injury bleeding in the treatment area
using the system 10 is important. The time required to load the
bandage 50 onto the system 10, deploy the bandage 50, and to
introduce additional bandages 50 to the treatment area (if needed)
is a preferred design feature.
[0028] Viewing the affected area is important for the proper
placement of the bandage over the injury. Therefore the device
should allow for the maximum viewing capability during diagnosis
and treatment (bandage application). If the device blocks the field
of view, it would be less favorable than one that does not block
any part of the viewing angle. This could happen if viewing depends
upon the endoscope's internal optics and the device extends beyond
the tip of the endoscope. The device should provide feedback to the
user (the physician) in such a way that assures the user of proper
deployment of the system 10 and accurate application of the
bandage. This should involve visualization of the properly adhered
bandage after application.
[0029] Oregon Medical Laser Center of Portland, Oreg., and its
licensee, Hemcon, have developed a bandage that can staunch the
flow of life-threatening bleeding. PCT patent application (WO
02/102276 A3) covering such a wound dressing was published on Dec.
27, 2002, and is incorporated herein in it's entirety by reference.
This bandage was designed for use on the battlefield, and has been
experimentally shown in a porcine model to prevent fatality in 100%
of cases in which the aorta was lesioned, as compared to 40% when
only gauze and pressure were used. Because the bandage is highly
effective, it has been FDA approved and has already been in use to
save lives by the U.S. Armed Forces.
[0030] A key component of the bandage is chitosan, which is a
deacylated derivative of the polysaccharide chitin. Chitosan has a
positive charge, and thus attracts and binds red blood cells and
platelets, which have a negative charge and are the major catalysts
for thrombosis. Also, the positive charge imparts strong
muco-adhesive properties to the chitosan bandage. Therefore, the
bandage has dual functionality: (a) it adheres to the injured
surface, protecting it from harsh external conditions and lessening
the amount of blood loss, and (b) it prevents continued bleeding by
creating an active clotting surface and seals the injured tissues
to stop bleeding, stabilize the wound, and creates an antimicrobial
surface.
[0031] In addition to all of the useful anti-hemorrhagic properties
of chitosan, it is also non-immunogenic and has antimicrobial or
antibiotic properties. Thus, the chitosan bandage not only works
efficiently to stop bleeding, but also helps to seal wounds.
Additionally, a polymeric or protein material, preferably in the
form of a fine Vicryl or Dexon mesh or the like, or matrix proteins
such as collagen or elastin which may also have other important
physiologic effects, serves to provide structure for the chitosan
without adding unwanted thickness or inhibiting range of movement
that is a non-sticking surface to prevent chitosan from sticking to
the delivery device as well as sticking to other surface that
adhesion is not desired.
[0032] As shown in FIG. 3, the bandage 50 is able to maintain an
imposed cylindrical shape and stay wrapped around the system 10.
The ability of the bandage to stay wrapped around the system was
tested in both an inflated and deflated condition. In the deflated
scenario, the bandage wrapped securely around the outside of the
system and did not fall off when tilted in several directions. As
the system was slowly inflated, the bandage diameter increased
along with the increased size of the system. However, the bandage
maintained the position wrapped around the outside of the inflated
system.
[0033] The bandage should have an appropriate thickness and
flexibility to be effective in adhering to the treatment area and
for hemorrhage control and/or tissue repair. Esophageal damage can
often be present around the entire circumference of the esophagus,
so it must be possible to cover this entire area. If one bandage is
not sufficient to do so, then the application of multiple bandages
may be possible. The bandage also must be non-toxic because it will
be positioned in the body and, after application, the patient will
eventually process the bandage through the digestive system.
[0034] The bandage's tubular shape is designed to encompass all
sides of the esophagus wall. It may also be compact so that there
is sufficient space which will allow more flexibility in the design
of the deployment device. Depending on the design of the system,
the bandage might need a protective barrier so that it will not
stick to the device or the sides of the esophagus en route to the
affected area. The bandage should preferably substantially adhere
within about 2-5 minutes of applied pressure.
[0035] The system 10 will deliver the bandage down the esophagus
and maintain the bandage's position on the system. The system will
provide protection from moisture of the esophageal wall during the
delivery. After reaching the affected treatment area, the system
will transfer the bandage from the endoscope or guide wire to the
treatment area. The system, will deploy the bandage and then
maintain position and apply pressure after the bandage is deployed.
The bandage will adhere to the wound and stop bleeding, and the
system will provide imaging of the treatment area.
[0036] As seen in FIGS. 1 and 2, the backbone of the preferred
system 10 is a long thin walled tubular sleeve 12, more preferably
a polymeric tube. The sleeve 12 can be formed of a long thin walled
piece of polymeric material such as nylon or DELRIN.RTM. (which is
an acetal polymer manufactured by Dupont). The preferred sleeve 12
is designed to slide easily over the outer diameter of the
endoscope tip. The ends 14, 16 of the sleeve preferably have
slightly smaller outer diameters, more preferably identified as a
locking ring recess. This allows locking rings 18 to fit tightly
over the ends 14, 16 of the sleeve and remain in a fixed
position.
[0037] A small hole 22 can be bored close to the edge of the sleeve
to allow for the attachment of an inflation tube. Typically, the
snug fit of the sleeve over the endoscope tip does not leave room
for the inflation tube to run along space between the sleeve and
the endoscope. Therefore, the length from the inflation hole to the
nearest edge would extend out beyond the tip of the endoscope. To
minimize the sleeve's extension beyond the endoscope, the inflation
hole was bored as close to the edge as possible. Two small holes 24
directly across from one another on the front-end locking ring
recess to allow for the insertion of a positioning wire 40.
[0038] Locking rings 18, 18' are preferably used to attach the
edges 14, 16 of the sleeve 12 and to create an airtight seal. The
locking rings 18, 18' are preferably formed of a polymeric material
such as nylon or DELRIN.RTM.. The edges 14, 16 of the rings 18 are
preferably beveled to aid in sliding them on the sleeve 12. The ID
of the rings 18, 18' is preferably slightly larger than the sleeve
recess OD, to account for the thickness of the expandable sleeve
30. The rings 18, 18' perform a locking function due to their tight
fit over the expandable sleeve 30. However, the rings 18, 18' are
not permanently attached and can be removed to replace the
expandable sleeve 30. The length of the rings 18, 18' are
preferably shorter than the length of the front locking ring recess
20 to allow for the insertion of positioning wire 60 on the locking
ring recess 20 as well.
[0039] The dimension of the front locking ring 18 preferably
differs from that of the back locking ring 18'. The front locking
ring 18 can be thin and, when secured on the sleeve 12, the OD of
the locking ring 18 is similar to the OD of the sleeve 12. After
deploying the bandage 50, the system 10 must be pulled back up the
esophagus, during which the front locking ring 18 must pass by the
adhered bandage. Limiting the size of the front locking ring 18
allows the front locking ring 18 to smoothly pass by the bandage,
whereas a protruding ring might get caught on the edge of the
bandage. The back locking ring 18' is generally relatively thick.
The thickness of the back locking ring 18' serves to prevent the
bandage from sliding backwards up the sleeve 12.
[0040] The sleeve 12 can be molded using an injection molding
technique. Its composition, if possible should match that of the
expandable sleeve 30 so that they can, alternatively, be bonded
together instead of being held in place by the locking rings 18,
18'. Typically, bonding is strongest between similar materials. The
sleeve 12 should have a small bending radius without restricting
flow, and should be compatible with the final choice of materials
for the sleeve 12. Preferably, a polymeric material such as low
udometer polyester (PET) can be employed. A PET expandable sleeve
30 can allow for significantly higher pressures to press the
bandage against the wall of the esophagus.
[0041] A guide wire with a clip (not shown) can direct the bandage
down the esophagus along the side of the endoscope or a tube of
fiber optics. The guide wire will extend from the wounded area in
the esophagus up to the patient's mouth, where it will be
maneuvered.
[0042] A positioning wire 60 can be threaded between the two
opposite holes 24 on the front end locking ring recess 20 and
secured in place with an adhesive material. After the locking ring
18 on the front end 16 is attached to the expandable sleeve 30, the
positioning wire 60 can be inserted through the holes 24.
Preferably, the positioning wire 60 is only attached to the sleeve
12 and not to the front locking ring 18. This allows the locking
ring 18 to be removable. Forceps can be used to grab the
positioning wire 60 in order to maintain the position of the system
10 on the endoscope tip, to push the system 10 off of the endoscope
tip, and to maneuver the system 10 inside the esophagus.
[0043] An inflation tube 32 is employed to introduce air into the
expandable sleeve 30 during adhering of the bandage to the
esophagus. The inflation tube 32 can be formed of a polymeric
material such as either polyethylene or a silicon material. A
segment of the inflation tube 32 can be threaded through the
inflation hole 22 from the center of the sleeve 12. An adhesive can
be used to secure the segment of the inflation tube 32 to the outer
surface of the sleeve 12. The inflation tube 32 preferably extends
the length of the endoscope through the center channel of the
endoscope. Once through the endoscope, the tube 32 is joined to a
Lure-Lock connector (not shown), which connects the tube 32 with a
syringe (not shown). The syringe can be used to inflate the
expandable sleeve 30 and deploy the bandage.
[0044] The expandable sleeve 30 is preferably a hollow
substantially cylindrical component comprising a body portion 34
and a neck portion 36 at each end of the body portion. The
expandable sleeve 30 is preferably designed so that the body
portion 34 assumes an extended tubular shape while the neck
portions 36 maintain a uniform ID cylindrical shape. The expandable
sleeve 30 can be slid over the sleeve 12, with the neck portions 36
lining up with the locking ring recess 20. The locking rings 18,
18' fit tightly over the locking ring recesses 20, securing the
neck portions 36 of the expandable sleeve 30. The expandable sleeve
30 can be inflated using a syringe attached to the inflation tube
32. The bandage is attached to the outside of the expandable sleeve
30 as shown in FIG. 3. A doctor can maneuver the bandage into
position using the system 10, and then inflate the expandable
sleeve 30 to a diameter slightly larger than the esophagus when
it's relaxed.
[0045] Sheath 70 is preferably a thin-walled, cylindrical polyester
heat-shrink tubing, typically with a substantially constant ID. The
sheath 70 is slid over the expandable sleeve 30 such that the front
end is aligned with the front end of the system 10 (see FIG.
4).
[0046] The front end of the sheath 70 is secured and sealed with a
sheath-securing flap 72 onto the system 10. The system, including
the attached sheath 70, is fit onto the tip of the endoscope. The
back end of the sheath is secured and sealed with surgical tape
onto the endoscope. With both ends secured, the bandage is enclosed
in a substantially watertight environment. Besides protecting the
bandage, a sheath can ideally push off the bandage from the
endoscope to the wound. The inner lips from sheath will push
against the bandage. Then, once the bandage is dislodged from the
endoscope, the sheath will retract to expose the bandage.
[0047] The extended expandable sleeve neck 36 on the back end of
the sleeve 12 is used to hold the bandage 50 in the same manner
that the sheath-securing flap 72 holds the sheath 70 (see FIG. 3).
The extended neck is rolled back and over the edge of the bandage.
The elastic properties and the texture of the silicon neck secure
the bandage with a fair amount of pressure. As a result, the
bandage does not easily slip off of the system 50 while the system
pushes through the sheath 70 and off of the endoscope towards the
treatment area. However, when the expandable sleeve 30 is inflated
to deploy the bandage 50, enough pressure is applied such that the
bandage-securing flap 52 loses its grip on the bandage and the
bandage is deployed.
[0048] The extended expandable sleeve neck 36 on the front end of
the expandable sleeve 30 is used to hold the sheath 70, which is
needed to keep the bandage dry as the system travels down the
esophagus. The extended neck is rolled back and over the end of the
sheath as one would roll up the bottom of one's pants. Stretching
the expandable sleeve neck over the sheath seals the end of the
sheath from water entry. The elastic properties and the texture of
the silicon neck secures the sheath with enough pressure so that
the sheath does not easily slip off of the system. Forceps can be
used to push on the wire with enough force. When this occurs, the
sheath-securing flap loses its grip on the sheath. The system
slides off the endoscope while the sheath remains secured to the
endoscope with surgical tape.
[0049] When assembling, the inflation tube and the positioning wire
are threaded through their respective holes and permanently secured
to the tube with an adhesive. The expandable sleeve is then slid
over the tube and enclosing the adhered inflation tube segment in
the expandable sleeve's body volume. Finally, the locking rings are
fitted over expandable sleeve necks on the locking ring recesses,
securing the expandable sleeve and forming an airtight space
between the expandable sleeve's body and the outer surface of the
tube.
[0050] Before operation of the system, the bandage and sheath must
be added. The pre-rolled bandage wraps around the system and is
secured by rolling the excess flaps of the expandable sleeve
overtop of the bandage. To protect the bandage from the wet
environment of the esophagus, the sheath, which is described above,
and which is preferably made of a polymeric material such as a
polyester, slides around the system outside of the bandage and is
also secured to the system with the front flap of the expandable
sleeve.
[0051] The system, along with the bandage and sheath, is now ready
to be loaded onto the endoscope. First, the expandable tubing is
threaded backwards up the channel of the endoscope from the tip
toward the doctor's end using the grasping forceps. Once the
inflation tube runs up the channel, the syringe attaches to the
inflation tube using tubing connectors. Before fixing the back end
of the sheath to the endoscope, the system is positioned around the
endoscope such that the positioning wire is within grasp of the
forceps. Throughout the operation, the forceps control and hold the
system by gripping the positioning wire.
[0052] Once the system is integrated with the endoscope, the
operation can begin. The endoscope with the system attached is
navigated down the esophagus until it reaches the wound. The
endoscope will be positioned such that the wound is within view.
The system is pushed forward with the forceps until it is released
from the sheath and reaches the site. The force of the forceps
overcomes the sealing power of the expandable sleeve flaps. The
back end of the sheath remains fixed and keeps the sheath in place
in order to expose the bandage. Next, the expandable sleeve is
inflated with air from the syringe. The flaps of the expandable
sleeve roll back off of the bandage as the expandable sleeve
inflates to fully expose the bandage to wound. Most importantly,
the inflation of the expandable sleeve applies pressure to the
bandage against the esophagus. The expandable sleeve must maintain
pressure on the bandage to ensure adequate adherence of the bandage
to the esophagus. Then, the expandable sleeve is deflated, and the
system is retracted from the treatment site back onto the end of
the endoscope using the forceps. The performance of the system and
bandage can be viewed with the monitor, which is attached to the
endoscope's internal imaging equipment. After deployment, the
resulting bandage can be examined to check for adherence and
accuracy of deployment.
Ex Vivo Testing The subject system's ability to successfully deploy
a bandage was tested on an excised esophagus.
[0053] The excised esophagus from a 450 lb. pig was attached to a
metal ring using clips. This ring was then secured onto a ring
stand, and the esophagus was suspended to its full length. The
system of the subject invention was loaded onto the endoscope.
Next, the system was inserted into the excised esophagus from the
proximal end, and pushed down to the approximate center of the
esophagus using the endoscope. The system was deployed and the
expandable sleeve was left inflated for about 3 minutes to allow
for sufficient adherence of a chitosan bandage to the esophagus.
The expandable sleeve was then deflated, and the system was pulled
out of the esophagus using the endoscope and forceps.
[0054] The esophagus was detached from the stand apparatus, and
then cut with scissors vertically down its entire length. The
bandage was pulled on using forceps in order to assess the degree
of adherence to the esophagus.
[0055] The sheath functioned successfully. It provided the bandage
with appropriate protection from moisture. This was determined
based on the fact that the bandage did not adhere to the sheath--an
event that would have occurred had the bandage become wet while the
sheath was still covering it.
[0056] The expandable sleeve functioned with success according to
the defined criterion. It was inflated with 20 ml of air, and,
based on observation of the outer profile of the esophagus, it
retained this volume of air throughout the 3-minute inflation
period.
[0057] The bandage adhered tightly to the esophageal lumen. The
bandage deployed in a uniform manner and covered the entire inner
circumference of the esophagus. When the bandage was pulled on with
forceps, it took the entire weight of the excised esophagus to
begin separating the bandage from the tissue.
In Vivo Testing The subject system's ability to successfully deploy
a bandage in vivo was tested in several live swine.
[0058] A gastroenterologist and selected medical staff conducted
the procedures. The system was loaded on to the end of an
endoscope. The pig was anesthetized to the point of
unconsciousness. The pig was incubated, and monitored closely by
qualified animal care professionals. The gastroenterologist
inserted the endoscope with the system into the pig via its mouth.
When the testing site was reached, the system was deployed, and a
chitosan bandage was attached to the pig's esophagus.
[0059] After the bandage was deployed, and the system was pulled
from within the animal, the entire system (including the sheath)
was removed from the endoscope so that the site of bandage
application could be investigated with the endoscope alone. After
thorough video observation, the endoscope was used to gently push
on the bandage to test for proper adherence. Additionally, the
endoscope was pushed past the bandage to test whether food could
still pass through the center hole.
[0060] For one of the trials, the system was testing bleeding
lacerations in the esophagus. The pig was heparinized to inhibit
its natural clotting abilities so that all clotting observed would
be due to the presence of the bandage. Next, the esophageal lumen
was lacerated using an endoscopic needle system to the point of
bleeding. The system was then used to deploy a bandage in the same
manner as previously described such that it covered the bleeding
wounds.
[0061] A bandage was deployed as described at the gastroduodenal
junction. Then, a bandage was deployed at the gastroesophageal
junction. Both bandage deployments (at the gastroesophageal
junction and the gastroduodenal junction) met all of the criteria
and were considered successes.
[0062] No adverse consequences were observed as a consequence of
delivering the dressing or dressing deployment.
[0063] A biopsy forceps was introduced and grabbed the adhered
dressing to determine the strength of adhesion. The bonding was
strong enough to allow pulling the stomach through the diaphragm,
indicating a very strong adhesion of the chitosan dressing to the
esophagus
[0064] Based on both the ex vivo and the in vivo testing results,
it was concluded that the system of the present invention could
accurately and consistently apply bandages rapidly and safely to
tissues in the esophagus and in the duodenum using conventional
endoscopes and endoscopic techniques.
* * * * *